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School of Medicine
CHEMISTRY AND PHARMACEUTICAL TECHNIQUES
Course unit
PRE-CLINICAL AND CLINICAL STUDIES OF NEW DRUGS
MEP3052595, A.A. 2019/20

Information concerning the students who enrolled in A.Y. 2015/16

Information on the course unit
Degree course 5 years single cycle degree in
CHEMISTRY AND PHARMACEUTICAL TECHNIQUES
FA1733, Degree course structure A.Y. 2009/10, A.Y. 2019/20
N0
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Number of ECTS credits allocated 6.0
Type of assessment Mark
Course unit English denomination PRE-CLINICAL AND CLINICAL STUDIES OF NEW DRUGS
Department of reference Department of Pharmaceutical and Pharmacological Sciences
Mandatory attendance
Language of instruction Italian
Branch PADOVA
Single Course unit The Course unit CANNOT be attended under the option Single Course unit attendance
Optional Course unit The Course unit can be chosen as Optional Course unit

Lecturers
Teacher in charge MONICA MONTOPOLI BIO/14

ECTS: details
Type Scientific-Disciplinary Sector Credits allocated
Core courses BIO/14 Pharmacology 6.0

Course unit organization
Period First semester
Year 5th Year
Teaching method frontal

Type of hours Credits Teaching
hours
Hours of
Individual study
Shifts
Laboratory 1.0 15 10.0 No turn
Lecture 5.0 40 85.0 No turn

Calendar
Start of activities 30/09/2019
End of activities 18/01/2020
Show course schedule 2019/20 Reg.2009 course timetable

Syllabus
Prerequisites: Knowledge is required of the general pharmacology (pharmacokinetics and pharmacodynamics) of pharmacotherapy and toxicology.
Target skills and knowledge: The aim of the course is to make student critical in an experimental approach:
Ability to identify models, techniques and experimental protocols for the study of the mechanism of action of a compound/drug
identify the pharmacological molecular target
ability to design experiments to study the toxicological profile
capacity of analysis of experimental data and scientific articles
know about the different phases of drug development in terms of pharmaco-toxicological
Examination methods: The exam consists of an oral exam at the end of the course
Assessment criteria: During the examination will evaluate the student's critical ability in dealing with a pharmacological study experimentally based on laboratory experience.
Course unit contents: The course aims to present the experimental pharmacological and toxicological from preclinical to clinical phase.
Methodologies for pre-clinical studies in vitro, ex vivo and in vivo pharmacological activity, pharmacokinetics and toxicity of new chemical entities (NCE) for the development of new drugs. Good Laboratory Practice (GPL). Identification of drug target. High Throughput Screening (HTS). Models of diseases, absorption, physiological barriers, transporters, receptors, biotransformation, genetic polymorphism, cytotoxicity, cardiotoxicity, neurotoxicity, carcinogenicity.
Clinical trial. Good Clinical Practices (GCP). Good manufacturing practice (GMP). Regulatory aspects for the authorization of clinical trials Phase I, II, III. Ethics Committees. Monitoring of the trial. Pharmacovigilance. Evidence-Based Medicine (EBM). Innovation, risk / benefit ratio, efficacy and effectiveness. Databases.
The laboratory involves performing pharmacological assays discussed during the lectures applying spectrophotometric techniques, flow cytometry, microscopic, etc..
Planned learning activities and teaching methods: The course includes 40 hours of lectures and 15 hours of laboratory exercises. In lectures by supporting slides will address the different topics. Each topic also provides an in-depth critical discussion of experimental data with the most current scientific literature.
The laboratory exercises (15 hours) provide for the performance by the student of pharmacological assays with cellular models and advanced methods such as flow cytometry, fluorescence microscopy, etc..
Additional notes about suggested reading: Lecture slides will be provided in paper format that will be the basis for addressing the exam.
During the course will be discussed experimental items that will be provided to students as a source of study.
Textbooks (and optional supplementary readings)